- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03759509
Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile
Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
When work shifts and lifestyles change, the synchronous relationship between the body's biological clock and the environment, i.e., circadian rhythms, is disrupted, resulting in insufficient sleep and insomnia. Shift work in nursing has been found to result in sleep disruption and sleep deprivation, and in sleepiness or fatigue at work. Slow reaction, insufficient attention and poor judgement often come with increased fatigue, which contributes to a high risk of accident and patient safety. Studies have shown that aerobic exercise is helpful in promoting high sleep quality, whereas few researchers have argued over how aerobic exercise training improves sleep quality in nurses. The study is conducted in two stages. Previous stage, we conducted with a cross-sectional study design with convenience sampled 200 participants to fill out the Chinese Pittsburgh Sleep Quality Index (CPSQI) questionnaire for screen the low sleep quality (CPSQI > 5) participants. A total of 200 nurses were recruited, and 199 valid samples were collected, 108 participants were found to have low sleep quality (CPSQI > 5). The study will adopt a prospective, longitudinal, parallel-group comparative study, randomly sample from previously screen low sleep quality participants, then random assign to experimental (aerobic exercise) and control (routine activity) groups, and actigraphy sleep recording, saliva samples and attention data will be collected.
The study aims to investigate the effects of aerobic exercise training on nurses' sleep quality, fatigue, attention and cortisol profile. The findings of the study could provide guidelines on improving nurses' fitness and sleep quality.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan, 110
- Taipei Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Full-time
- Female nursing staff members
- Worked 8 hours per shift
- Had at least 1 year of work experience.
Exclusion Criteria:
- Had used sedatives, hypnotics, antihistamines, or hormonal drugs within the 4 weeks before commencing the study
- Pregnant
- Were diagnosed as having sleep or stress disorders, or experienced sleep problems owing to concurrent insomnia or sleep apnea.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: aerobic exercise training
three times a week, a total of twenty-four times in eight weeks
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the experimental group, in which aerobic exercise training is given three times a week, a total of twenty-four times in eight weeks
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No Intervention: control
routine activity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total sleep time sleep change
Time Frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
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The actigraphy reported on sleep parameters of the amount of actual sleep minutes
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The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
|
Wake after sleep onset change
Time Frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
|
The actigraphy reported on the amount of minutes they were awake between sleep onset and wake time.
|
The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
|
Sleep efficiency change
Time Frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
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The actigraphy reported on sleep parameters of percentage of time asleep while in bed from lights off to lights on.
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The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
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Seep onset latency change
Time Frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
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The actigraphy reported on sleep parameters of the minutes between lights off and first sleep episode.
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The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Simple visual reaction time testing
Time Frame: Before and after work, the test are completed within 5 min
|
Psychomotor Vigilance Task Monitor to test simple visual reaction time
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Before and after work, the test are completed within 5 min
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Saliva cortisol
Time Frame: Collected at awakening [0 min] and at 30 min, 6 hours, and 12 hours after awakening
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Diurnal cortisol concentration
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Collected at awakening [0 min] and at 30 min, 6 hours, and 12 hours after awakening
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: shu fen Niu, PhD, Taipei Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMU-JIRBN201711007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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